Objective To establish an accurate and reliable HPLC/UV method for the quantitative determination of nicotinic acid in nicotinic acid tablets. Methods The chromatographic separation conditions employed for HPLV method were chosen using Aglient C18 column. 0. 02 mol/L potassium dihydrogen phosphate (Ph 6. 8)-acetonitrile (90:10) were used as the mobile phase pumped at a flow rate of 1. 0mL/min and a detection wavelength at 263 nm was used. UV method use potassium dihydrogen phosphate (Ph 6. 8)-acetonitrile (90:10) as solvent,and the detection wavelength were at 263 nm. The linearity,precision,accuracy,recovery rate and other content were tested to validate the method. Results The linear range of nictinic acid was 5. 0~100. 0 μg/mL. With UV method (r=0. 995 9),the average recovery is 99. 57%(RSD=1. 08%,n=6);with HPLC method (r=0. 999 8),the average recovery is 99. 62% (RSD=0. 74%,n=6).Conclusion The HPLC/UV method is simple,accurate,high-specificial and reproducible. This method can be used for the quality control nicotinic acid tablets.%目的 建立一种精确可靠的 HPLC/UV 法用于测定烟酸片中烟酸的含量. 方法:HPLC 法采用Aglient C18色谱柱,以0. 02 mol/L 磷酸二氢钾-乙腈(90:10)为流动相等度洗脱,流速1. 0 mL/min,检测波长263 nm;UV法以磷酸二氢钾-乙腈作为溶剂,在263 nm 波长处测定吸光度;并通过检测其线性范围、精密度、准确度和加样回收率对该方法进行验证. 结果:烟酸检测质量浓度在5. 0~100. 0μg/mL 范围内,与吸光度和峰面积积分值呈良好的线性关系,UV法检测r=0. 9959,平均加样回收率为99. 57%,RSD=1. 08%(n=6);HPLC法检测r=0.999 8,平均加样回收率为99. 62%,RSD=0. 74%(n=6). 结论:HPLC法和UV法联用操作简捷、准确、重复性好,并且具有更好的专属性,可用于烟酸片烟酸的含量测定和质量控制.
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